The Dose Trial: Dose Intensity of Behavioral Interventions for Childhood Obesity

Part of paid clinical trials in Baton Rouge, Louisiana.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06654323
Status
Recruiting
Apply to this trial

Conditions

  • Childhood Obesity

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Intensive Behavioral Lifestyle Modification — BEHAVIORAL
    Participants in all arms will receive visits with their child's primary care provider (4 visits, 1 hour total), on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), and community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total). The difference between arms will be in the frequency and duration of personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session), 12 sessions (60 minutes per session), 9 sessions (60 minutes per session), 8 sessions (45 minutes per session), or 6 sessions (30 minutes per session).

Study Details

The research team is recruiting 900 children between the ages 5-17 with obesity from Tennessee and Louisiana. The team is assigning children and their caregivers by chance to one of five groups. In the first group, 300 children and their caregivers receive 26 hours of IBT. In the second group, 300 children and their caregivers receive 13 hours of IBT. The remaining three groups of 100 children and their caregivers receive 16, 19, or 22 hours of IBT. Children's healthcare providers, nutritionists, and social workers are providing IBT to each of the groups over six months. At the start of the study and again after one year, the research team is measuring the children's body mass index, or BMI. BMI is a measure of a person's body fat based on their height and weight. The team is also looking at the children's: * Diet * Exercise * Sleep * Media use * Quality of life

Key Dates

Start date
Feb 20, 2025
Status verified
Aug 2025
Primary completion
Aug 1, 2028
Completion
Aug 1, 2028

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 26-hour intensive behavioral lifestyle intervention
    Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional: 16 sessions (60 minutes per session).
  • Active Comparator: 22-hour intensive behavioral lifestyle intervention
    Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 12 sessions (60 minutes per session).
  • Active Comparator: 19-hour intensive behavioral lifestyle intervention
    Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professiona for 9 sessions (60 minutes per session).
  • Active Comparator: 16-hour intensive behavioral lifestyle intervention
    Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 8 sessions (45 minutes per session).
  • Active Comparator: 13-hour intensive behavioral lifestyle intervention
    Participants will receive 4 visits, (1 hour total) with their child's pediatric primary care provider, on-demand web-based learning modules that focus on building skills and knowledge in health behaviors (7 hours), community resource counseling sessions delivered by a social worker or similar healthcare professional (4 sessions, 2 hours total), and personalized nutrition counseling delivered by a registered dietitian or similar healthcare professional for 6 sessions (30 minutes per session).

Primary Outcome Measure

Percent of the 95th BMI Percentile [ Time Frame: 5 times over 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Pennington Biomedical Research CenterBaton RougeLouisiana70808
Natalie Malek
[email protected]
225-763-2899
Vanderbilt University Medical CenterNashvilleTennessee37212
Filoteia Popescu
[email protected]
615-875-9083

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By research site
Pennington Biomedical Research Center· Baton Rouge, LAVanderbilt University Medical Center· Nashville, TN

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